Medical Device Manufacturer · US , Shirley , NY

Biodex Medical Systems, Inc. - FDA 510(k) Cleared Devices

9 submissions · 8 cleared · Since 1994

Recent clearances: ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336, SHARPS CONTAINER, MODEL 039-413, BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP

View 9 510(k) Devices ↓

9

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biodex Medical Systems, Inc. Physical Medicine ✕

6 devices

1-6 of 6

Cleared Nov 16, 1995

BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP

Physical Medicine · 213d

Cleared Mar 10, 1995

STABILITY SYSTEM (110V) MODEL 945-300

Physical Medicine · 276d

Cleared Dec 28, 1994

Physical Medicine · 338d

Cleared Sep 16, 1994

LOWER BODY CYCLES

Physical Medicine · 330d

Cleared Sep 16, 1994

SEMI-RECUMBENT CYCLES

Physical Medicine · 325d

Cleared Sep 16, 1994

UPPER BODY CYCLES (110 VOLT)/(220 VOLT)

Physical Medicine · 302d